Lormetazepam 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lormetazepam

Available from:

Waymade Healthcare Plc

ATC code:

N05CD06

INN (International Name):

Lormetazepam

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010100

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LORMETAZEPAM 1MG TABLETS
Your medicine is called Lormetazepam 1mg Tablets but
throughout this leaflet they will be referred to as
Lormetazepam Tablets.
Lormetazepam Tablets are available in strengths of
0.5mg & 1mg.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.

If any of the side-effects get serious, or if you notice any
side-effects not listed in this leaflet, please tell your
doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1.
What Lormetazepam Tablets are and what they are used
for
2.
Before you take Lormetazepam Tablets
3.
How to take Lormetazepam Tablets
4.
Possible side-effects
5.
How to store Lormetazepam Tablets
6.
Further information
1.
WHAT LORMETAZEPAM TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Lormetazepam Tablets.
Lormetazepam is a member of a group of medicines called
benzodiazepines. Lormetazepam is used for short-term
therapy to help with sleeping difficulties which are
significantly affecting your normal daily life.
2.
BEFORE YOU TAKE LORMETAZEPAM TABLETS
WARNINGS AND PRECAUTIONS:
Talk to your doctor before using Lormetazepam Tablets:

if you have severe breathing or chest problems

if you are allergic to benzodiazepines or any of the other
ingredients in Lormetazepam Tablets (see list under
‘What Lormetazepam Tablets contain’)

if you have myasthenia gravis (very weak or tired
muscles)

if you have serious liver problems

if you suffer from sleep apnoea (breathing problems
when you are asleep)

if you are breastfeeding, since the drug may pass into
breast milk.
TAKE SPECIAL CARE WITH LORMETAZEPAM TABLETS:

if you are pregnant, or trying to become pregnant
(see below)

if you abuse or have in the past a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lormetazepam 1 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.00 mg of lormetazepam
_Excipients with known effect:_
Each tablet contains 86.40 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Round white tablets, scored on one side.
The tablet can be divided into equal doses.
Round white tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of insomnia.
Benzodiazepines are only indicated when the disorder is severe,
disabling or
subjecting the individual to extreme distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and duration of therapy should be individualised. The lowest
effective
dose should be prescribed for the shortest time possible. Generally,
it varies
from a few days to two weeks with a maximum period, including gradual
reduction, of four weeks.
Adults: 0.5mg to 1.5mg before retiring. Subsequently the initial
dosage may be
increased to 2 mg in individual cases if this proves necessary.
Elderly: The lower adult dose is preferable for elderly patients.
_Paediatric population _
Lormetazepam must not be used in children and adolescents under 18
years of age
without a careful assessment of the need for the treatment.
For patients with mild to moderate chronic respiratory insufficiency
or hepatic
insufficiency a dose reduction should be considered.
The tablets should be taken with a small amount of liquid before going
to bed.
4.3
CONTRAINDICATIONS
Lormetazepam is contraindicated in patients with:
•
Hypersensitivity to benzodiazepines or to any of the excipients of
Lormetazepam
tablets
•
Myasthenia gravis
•
Severe respiratory insufficiency (for example, severe chronic
obstructive
pulmonary disease), sleep apnoea syndrome.
•
Acute intoxication with alcohol, hypnotics, analgesics or psychotropic
drugs
(neuroleptics, antidepressants, lithium).
•
Severe liver insufficiency.
Pregnancy and lactation (see also 4.6 “Fertility,